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New epilepsy drug shows promise for Long-Term seizure control

NCT ID NCT03961568

Disease control Sponsor: SK Life Science, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at the long-term safety of the drug cenobamate when added to existing treatment for people with primary generalized tonic-clonic seizures. A total of 147 participants who completed an earlier study took cenobamate for up to 52 weeks. Researchers tracked side effects, lab results, and vital signs to see how well the drug was tolerated over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cenobamate
What this could lead to
If successful, this could confirm cenobamate as a safe long-term add-on treatment to reduce seizure frequency in people with generalized epilepsy.
What could go wrong
This is an open-label extension study, so there is no placebo group for comparison. Side effects may still emerge, and the results may not apply to all epilepsy types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

147 people

The number who actually took part.

Started

Aug 2019

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * The subject must have successfully completed the Double-blind Treatment Period in the Core study. * Written informed consent signed by the subject or legal guardian, prior to entering the study, in accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. If the written informed consent is provided by the legal guardian because the subject is unable to do so, a written or verbal assent from the subject must also be obtained. As required by country-specific regulations, only the subject may sign the ICF in accordance with ICH guidelines. Exclusion Criteria: * Subject tests positive, via urine drug screen at Visit 14 of the Core study, for illicit drugs except for tetrahydrocannabinol and Cannabinoids. * Any significant changes to the subject's medical history that, in the opinion of the Principal Investigator, could affect the subject's safety or conduct of the study.

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Conditions

The condition(s) this trial relates to.

idiopathic generalized epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary generalized tonic clonic seizures in the setting of idiopathic generalized epilepsy

Contacts and locations

Locations

  • Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD

    Sofia, Sofia, 1407, Bulgaria

  • Centrum Leczenia Padaczki i Migreny

    Krakow, Lesser Poland Voivodeship, 31-209, Poland

  • Centrum Medyczne Pratia Warszawa

    Warsaw, Masovian Voivodeship, 01-868, Poland

  • Cerebrovaskularni poradna

    Ostrava-Poruba, 708 52, Czechia

  • Clinical Research Center Spólka z Ograniczona Odpowiedzialnoscia Medic-R sp. k.

    Poznan, Greater Poland Voivodeship, 60-848, Poland

  • Communal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnikov", Regional Center

    Dnipro, 49005, Ukraine

  • Communal Non-Commercial Enterprise of Kharkiv Regional Council

    Kharkiv, 61068, Ukraine

  • Consultants in Epilepsy and Neurology, PLLC

    Boise, Idaho, 83702, United States

  • Diagnostic Consultative Center Equita EOOD

    Varna, Varna, 9000, Bulgaria

  • Diagnostic Consultative Center Neoclinic EAD

    Sofia, Sofia, 1408, Bulgaria

  • Duke University

    Durham, North Carolina, 27705, United States

  • Fakultni nemocnice v Motole

    Prague, 150 06, Czechia

  • Five Towns Neuroscience Research

    Woodmere, New York, 11598, United States

  • Forbeli s.r.o.-Neurologicka ambulance

    Prague, 160 00, Czechia

  • Górnoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach

    Katowice, Silesian Voivodeship, 40-635, Poland

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii, 96814, United States

  • IN MEDIC s.r.o.

    Bardejov, 085 01, Slovakia

  • Konzilium, s.r.o.

    Dubnica nad Váhom, 018 41, Slovakia

  • MUDr. Beata Dupejova, neurologicka ambulancia, s.r.o.

    Banská Bystrica, 974 04, Slovakia

  • Maine Medical Center

    Scarborough, Maine, 04074, United States

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 01056, United States

  • Medical Center Medica Plus OOD

    Veliko Tarnovo, Veliko Tarnovo, 5000, Bulgaria

  • Mid-Atlantic Epilepsy and Sleep Center

    Bethesda, Maryland, 20817, United States

  • Minneapolis Clinic of Neurology

    Golden Valley, Minnesota, 55422, United States

  • MultiCare Rockwood Neurology Center

    Spokane, Washington, 99204, United States

  • Multiprofile Hospital for Active Treatment Puls AD

    Blagoevgrad, Blagoevgrad, 2700, Bulgaria

  • Multiprofile Hospital for Active Treatment Sv. Ivan Rilski Gorna Oryahovitsa EOOD

    Veliko Tarnovo, Veliko Tarnovo, 5100, Bulgaria

  • Municipal Institution "Dnipropetrovsk City Clinical Hospital No16" of Dnipropetrovsk Regional Council

    Dnipro, Dnipropetrovsk Oblast, 49027, Ukraine

  • Municipal Institution "Dnipropetrovsk Regional Clinical Hospital named after I. I. Mechnikov"

    Dnipro, 49005, Ukraine

  • Municipal Institution "Vinnytsia Regional Psychoneurological Hospital named after Acad. O.I. Yushch

    Vinnytsia, 21005, Ukraine

  • Municipal Institution Odesa Regional Clinical Hospital, Department of Cerebro-Vascular Diseases

    Odesa, Odesa Oblast, 65025, Ukraine

  • Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council

    Zaporizhzhya, Zaporizhzhya, 69600, Ukraine

  • Municipal Institution of Lviv Regional Council

    Lviv, 79010, Ukraine

  • Neurologicka ambulance

    Zlín, 760 01, Czechia

  • Northeast Regional Epilepsy Group

    Hackensack, New Jersey, 07601, United States

  • Regional Clinical Center of Neurosurgery and Neurology "Uzhhorod National University"

    Uzhhorod, Zakarpattia Oblast, 88018, Ukraine

  • Regional Psyconeurology Hospital #3

    Ivano-Frankivsk, 76011, Ukraine

  • Semmelweis Egyetem I. Sz. Gyermekgyogyaszati Klinika

    Budapest, 1083, Hungary

  • Ternopil Regional Municipal Psychoneurological Hospital

    Ternopil, 46020, Ukraine

  • The Neurology Research Group, LLC.

    Miami, Florida, 33176, United States

  • University of California, San Diego (UCSD)

    La Jolla, California, 92093, United States

  • University of Missouri Medical School

    Columbia, Missouri, 01074, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19140, United States

  • University of South Florida

    Tampa, Florida, 33606, United States

  • Valley Medical Center

    Renton, Washington, 98057, United States